Regulatory Affairs Senior Associate

What You Will Do In this role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Responsibilities Assist US Regulatory Lead (USRL) to support US regulatory activities such as development and submission of Investigational New Drug (IND), Biologic License Applications (BLAs) and New Drug Applications (NDAs); prepare advisory committee meetings. Provide and maintain IND/BLA/NDA documentation support, including annual reports and amendments. Create and maintain product regulatory history documents in the regulatory document management system and archive all regulatory documents and agency communications. Review the US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; conduct regulatory research to support content development. Actively support regulatory compliance and ensure compliance of submissions to the US FDA. Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including regulatory landscapes, research for strategy or target product label. Coordinate collection of functional documents in support of regulatory applications. Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with meeting management (agendas, minutes). Assist the USRL in managing the process for responding to FDA questions. Coordinate Quality Check (QC) of regulatory documentation such as briefing packages. Provide primary authorship to routine regulatory correspondence, e.g., annual reports. Prepare regulatory packages and cross‑reference letters to support investigator‑initiated studies. Complete regulatory forms to support agency communications (e.g., FDA form 1571). Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance. Respond to specific requests and communicate relevant issues to GRT. Support the development and execution of GRT goals. Basic Qualifications Master’s degree; or Bachelor’s degree and at least 2 years of regulatory or pharmaceutical experience; or Associate’s degree and at least 6 years of regulatory or pharmaceutical experience; or high‑school diploma/GED and at least 8 years of regulatory or pharmaceutical experience. Benefits A comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Salary Range 83,974.90USD – 113,613.10USD (excluding Puerto Rico). Salary depends on relevant skills, experience, and qualifications. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. #J-18808-Ljbffr Amgen Inc. (IR)